EP4436985A4 - Rekombinantes botulinum-neurotoxin vom typ a und herstellungsverfahren dafür - Google Patents

Rekombinantes botulinum-neurotoxin vom typ a und herstellungsverfahren dafür

Info

Publication number
EP4436985A4
EP4436985A4 EP23810945.8A EP23810945A EP4436985A4 EP 4436985 A4 EP4436985 A4 EP 4436985A4 EP 23810945 A EP23810945 A EP 23810945A EP 4436985 A4 EP4436985 A4 EP 4436985A4
Authority
EP
European Patent Office
Prior art keywords
manufacturing process
botulinum neurotoxin
process therefor
neurotoxin type
recombinant botulinum
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23810945.8A
Other languages
English (en)
French (fr)
Other versions
EP4436985A1 (de
Inventor
Yubao Shen
Guoqing Bao
Liming Guo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jhm Biopharmaceutical Hangzhou Co Ltd
Original Assignee
Jhm Biopharmaceutical Hangzhou Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202210572145.3A external-priority patent/CN114989271B/zh
Priority claimed from CN202211112222.3A external-priority patent/CN115894641B/zh
Application filed by Jhm Biopharmaceutical Hangzhou Co Ltd filed Critical Jhm Biopharmaceutical Hangzhou Co Ltd
Publication of EP4436985A1 publication Critical patent/EP4436985A1/de
Publication of EP4436985A4 publication Critical patent/EP4436985A4/de
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/70—Vectors or expression systems specially adapted for E. coli
    • C12N15/72—Expression systems using regulatory sequences derived from the lac-operon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/66—Enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/70—Vectors or expression systems specially adapted for E. coli
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/52—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from bacteria or Archaea
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24069—Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/86—Products or compounds obtained by genetic engineering
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12R—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
    • C12R2001/00—Microorganisms ; Processes using microorganisms
    • C12R2001/01—Bacteria or Actinomycetales ; using bacteria or Actinomycetales
    • C12R2001/185—Escherichia
    • C12R2001/19—Escherichia coli

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Epidemiology (AREA)
  • Toxicology (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Neurology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Birds (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Neurosurgery (AREA)
EP23810945.8A 2022-05-24 2023-05-18 Rekombinantes botulinum-neurotoxin vom typ a und herstellungsverfahren dafür Pending EP4436985A4 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202210572145.3A CN114989271B (zh) 2022-05-24 2022-05-24 重组a型肉毒素的制备方法
CN202211112222.3A CN115894641B (zh) 2022-09-13 2022-09-13 A型肉毒素突变体及其基因工程菌的构建
PCT/CN2023/095060 WO2023226873A1 (en) 2022-05-24 2023-05-18 Recombinant botulinum neurotoxin of type a and preparation method thereof

Publications (2)

Publication Number Publication Date
EP4436985A1 EP4436985A1 (de) 2024-10-02
EP4436985A4 true EP4436985A4 (de) 2025-10-15

Family

ID=88918474

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23810945.8A Pending EP4436985A4 (de) 2022-05-24 2023-05-18 Rekombinantes botulinum-neurotoxin vom typ a und herstellungsverfahren dafür

Country Status (5)

Country Link
US (1) US20240240168A1 (de)
EP (1) EP4436985A4 (de)
JP (1) JP7760716B2 (de)
KR (1) KR20240038789A (de)
WO (1) WO2023226873A1 (de)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI82266C (fi) * 1982-10-19 1991-02-11 Cetus Corp Foerfarande foer framstaellning av il-2 -mutein.
US20060024794A1 (en) * 2004-07-30 2006-02-02 Shengwen Li Novel methods for production of di-chain botulinum toxin
DE102005002978B4 (de) * 2005-01-21 2013-04-25 Merz Pharma Gmbh & Co. Kgaa Rekombinante Expression von Proteinen in einer disulfidverbrückten, zweikettigen Form
IL285634B2 (en) * 2019-02-21 2025-06-01 Merz Pharma Gmbh Co Kgaa Novel uses of botulinum neurotoxin for the treatment of tremor
CN111944036B (zh) * 2019-05-14 2024-09-06 上海盖浦生物科技有限公司 一种增殖免疫细胞的突变体蛋白
CN113156105A (zh) * 2021-01-27 2021-07-23 中国人民解放军军事科学院军事医学研究院 一种a型肉毒毒素快速定量检测卡
CN115894641B (zh) * 2022-09-13 2023-09-29 君合盟生物制药(杭州)有限公司 A型肉毒素突变体及其基因工程菌的构建
CN114989271B (zh) * 2022-05-24 2023-09-19 君合盟生物制药(杭州)有限公司 重组a型肉毒素的制备方法

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
L�PEZ DE LA PAZ MANUELA ET AL: "Rational design of botulinum neurotoxin A1 mutants with improved oxidative stability", TOXICON, vol. 147, 1 June 2018 (2018-06-01), US, pages 54 - 57, XP055924500, ISSN: 0041-0101, DOI: 10.1016/j.toxicon.2017.10.011 *
MUSHRUSH DARREN J. ET AL: "Studies of the Mechanistic Details of the pH-dependent Association of Botulinum Neurotoxin with Membranes", JOURNAL OF BIOLOGICAL CHEMISTRY, vol. 286, no. 30, 1 July 2011 (2011-07-01), US, pages 27011 - 27018, XP093311388, ISSN: 0021-9258, Retrieved from the Internet <URL:https://pdf.sciencedirectassets.com/778417/1-s2.0-S0021925819X41368/1-s2.0-S0021925819485177/main.pdf?hash=412f3ac0c8be1d9f3042e03c60d6c2c4bb8c260425db7acafe46e9be76219c3a&host=68042c943591013ac2b2430a89b270f6af2c76d8dfd086a07176afe7c76c2c61&pii=S0021925819485177&tid=spdf-b10ef54d-d0d3-41a7-8907-889> DOI: 10.1074/jbc.M111.256982 *
See also references of WO2023226873A1 *

Also Published As

Publication number Publication date
JP7760716B2 (ja) 2025-10-27
WO2023226873A1 (en) 2023-11-30
KR20240038789A (ko) 2024-03-25
JP2024535057A (ja) 2024-09-26
EP4436985A1 (de) 2024-10-02
US20240240168A1 (en) 2024-07-18

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